- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and execution and reporting of all global oncology medical affairs operations clinical trial activities, ensuring adherence to timelines, budgets, project, and ... tracking of milestones as per contract). Ensure the global clinical operations systems for management of company...to process standards and tools to achieve excellence in trial operations and management .Monitor and ensure compliance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …time management skills preferred.Experience with PH.1 - PH. IV clinical trial vendor contracts required.Experience with CRO contracts preferred.Demonstrated ... and execution of master agreements on a timely basis. Management and oversight of Clinical Development contracting...Life Sciences required Experience Qualifications4 or More Years in clinical trial outsourcing, health sciences or related… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …knowledge of CLIA/CAP regulations and GLP guidelines preferredBasic knowledge of clinical trial design; understanding of the overall drug development ... around rare diseases and immune disorders. Job Summary The Biosample Operations Manager , Biosample Management is responsible for supporting the oversight of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and updates Study Supply Plans in close communication with CSO project Management LeadResponsible for the Clinical Label Development process which includes ... Role is an Individual Contributor and sits at the Manager Grade level. This position is responsible for enabling...Qualifications7 or More Years of related experience, including Project Management , Clinical Supply Management , and/or… more
- Eisai, Inc (Nutley, NJ)
- …includes overseeing the daily global eTMF system related activities relating to clinical study Trial Master Files (TMF), ensuring regulatory inspection-readiness ... profile, we want to hear from you. The Sr. Manager is to lead collaboration efforts with R&D IT...validation or user acceptance testing, and integrations with other clinical applications through change management . Maintains the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and leads technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing ... laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard problems of some… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and execution and reporting of all global oncology medical affairs operations clinical trial activities, ensuring adherence to timelines, budgets, project, and ... tracking of milestones as per contract). Ensure the global clinical operations systems for management of company...to process standards and tools to achieve excellence in trial operations and management .Monitor and ensure compliance… more
- Merck (Rahway, NJ)
- …(CRF) data, lab data, biomarker data, and patient reported outcomes. + Serve as project manager of all clinical data management activities for trials as ... team is recruiting for summer interns within the trial manager area of our company. The...clinical data management perspective. + Provide clinical data management input into trial… more
- Merck (Rahway, NJ)
- … clinical documents. The Clinical Trial Coordinator CTC supports clinical supply & non- clinical supply management and ensures timely maintenance ... line- manager , this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing... trial databases (CTMS) and trackers + Clinical supply & non- clinical supply management… more
- Merck (Rahway, NJ)
- … clinical documents. The Clinical Trial Coordinator CTC supports clinical supply & non- clinical supply management and ensures timely maintenance ... line- manager , this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing... trial databases (CTMS) and trackers + Clinical supply & non- clinical supply management… more
- Astellas Pharma (New York, NY)
- …support. The Site Manager will partner with Clinical Trial Lead (CTL,) Clinical Trial Manager (CTM,) Clinical Trial Specialist (CTS,) and ... sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures...data and essential documents in relevant systems used for trial management . + Fully documents trial… more
- Hackensack Meridian Health (Hackensack, NJ)
- …meetings as required. + Serves as a Super User and team resource for the Clinical Trial Management System, Electronic Medical Records System, and all other ... comprehensive workflows and project/patient tracking procedures and tools to ensure ongoing clinical trial compliance across the assigned Research Program or… more
- Terumo Medical Corporation (Somerset, NJ)
- Sr. Manager , Clinical Advisors Date: Aug 27, 2024...groups and health systems. + Drive the analysis of clinical trial data, prepare and report trial ... on medical and scientific questions/issues during trial follow-up phase). + Review CEC/DMC/ Clinical trial reports. + Provide medical- clinical trial … more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …etc. + Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) ... etc. + Ensures compliance with the clinical trial registry requirements + Identifies outsourcing...vendor management experience + Technical proficiency in trial management systems and MS applications including… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …etc. + Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) ... etc. + Ensures compliance with the clinical trial registry requirements + Identifies outsourcing...vendor management + Advanced technical proficiency in trial management systems and MS applications including… more
- Stryker (Mahwah, NJ)
- …experience in clinical data management , preferably device or pharmaceutical clinical trial + Proficiency in EDC systems, (eg, Medidata Rave, Oracle) ... **cal Data Manager ,** you will be the clinical data management expert within the Joint...+ Develop complex status reports, specifications for analysis of clinical trial data for interim and final… more
- Bristol Myers Squibb (Madison, NJ)
- …Summary / Objective** + Will be responsible for design and execution of assigned clinical trial activities and work closely with clinical team members ... activities associated with the conduct + May serve as Clinical Trial Lead for one or more...with instruction + Provide regular and timely updates to manager / management as requested + Develop Protocol and… more
- Hackensack Meridian Health (Hackensack, NJ)
- …years of basic science lab work experience. + Minimum of 3 years of cancer clinical trial data management experience. + Excellent computer and analytical ... and serve as a leader of positive change. The ** Manager , Clinical Research** is responsible for ... Clinical Data Coordinators, Diagnostic Technicians, and other clinical trial support staff: schedules assignments and… more
- The Mount Sinai Health System (New York, NY)
- … Trials Manager , you will coordinate and manage multiple clinical trial projects and protocols, including federally funded studies, investigator-initiated ... the Tisch Cancer Institute. **RESPONSIBILITIES** + Manages and coordinates clinical trial and related research studies conducted...field; Masters preferred + 6+ years of experience managing clinical trials, including 2 years in a management… more
- Abbott (New York, NY)
- …initiatives. The Clinical Lead Specialist is to support Abbott TAVI US clinical trial and commercial case coverage, trial enrollment and sales ... in collaboration with the Regional Sales Directors and the Clinical Lead Manager (CLM). This position will...proper patient selection. + Serving as primary resource for clinical trial and lead/coach/commercial case support, demonstrating… more
